Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.

Heart Failure Clinical Trial

Official title:

Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02237820
• Other study ID #: no specific protocol ID
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: Rabin Medical Center
• Contact: Alon Y Grossman, MD
• Phone: 972-3-9376606
• Email: ALONG[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of HF patients hospitalized with exacerbation of COPD. The study may provide important data regarding a simple but potentially robust intervention among large patient population with high rates of hospital admissions.

Description:

An Open-label randomized prospective study of HF patients (NYHA grade II-VI), hospitalized with COPD exacerbation. Eighty patients will be randomized in a 1:1 fashion to conventional and intervention testament groups. Informed consent will be obtained from all patients prior to study enrolment.

Randomization will be performed using RED cap - secure web application. The conventional therapy group will receive 40mg of oral prednisone daily, while the intervention group will be treated with oral dexamethasone in an equivalent anti-inflammatory dose of 6 mg/day. Glucocorticosteroids will be administered throughout hospitalization and will be continued for at least 5-7 days. Dose changes through this period, as well as subsequent tapering will be on the discretion of the treating physician. All patients will also be treated with short-acting bronchodilators, antibiotics, oxygen, positive pressure non-invasive mechanical ventilation and VTE prophylaxis - based on the GOLD 2019 guidelines and clinical judgment of the attending physicians. An order for low sodium diet will be written. Discharge decisions will be based on the GOLD 2019 discharge criteria list. Patients will be discharge without steroid tapering regimen unless indicated by clinical judgment. Patient's demographic data will be documented at baseline (age, sex, GOLD severity stage, data on hospitalizations in the past year, patients' chronic drug therapy, Last spirometry and two-dimensional echo-Doppler examination results).

On admission, patients' weight, height and oxygen saturation will be measured and routine blood tests will be drawn for evaluation of complete blood count, chemistry, NT proBNP levels, troponin, C-reactive protein and venous blood gas. Blood test results will be taken from the patient electronic medical record and will be based on the tests taken in the ER and during ward admission. Upon recruitment, the patient will be asked to complete COPD assessment tool (CAT) questionnaire and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12, the short form version) in order to quantify their health status. A follow-up telephone call visit will be performed 14±2 and 28±2 days after enrollment. The following measures will be obtained: KCCQ-12 and CAT questionnaire scores and documentation of current diuretic dose. After study completion, each patient will be followed for 30 more days post admission in order to document further hospitalizations.

All the date collected during the study and after patients enrollment will be documented on a specialized case report form (CRF) built on RED cap - secure web application.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Age > 40 years.

• Patients with a previous diagnosis of COPD and evidence of airflow limitation (GOLD severity stage of II-IV).

• Patients with COPD exacerbation and potential indications for hospitalization as defined by the 2019 GOLD guidelines.

• Patients with a diagnosis of heart failure (NYHA grade II-IV).

Exclusion criteria:

• Patients with a severe exacerbation on enrollment, based upon arterial PH<7.2 or PaCO2 > 90 mmHg

• Patients who are currently participating in other studies.

• Known hypersensitivity to prednisone / dexamethasone.

• Patients who were treated with systemic corticosteroids one month prior to admission, unless prednisone dosage is 20 mg or less.

• Patients who are unable to provide an informed consent.

• Pregnant woman.

• Patients on Chronic mechanical ventilation.

Study drug treatment termination criteria:

• Hypersensitivity reaction to prednisone / dexamethasone.

• Any clinical deterioration, which at the discretion of the treating physician and/or study investigators, necessitate change of the study steroid treatment (such as, but not limited to, need to stop oral medication).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Dexamethasone
6 mg/day of Oral Dexamethasone
• Prednisone
40 mg/day of Oral Prednisone

Locations

Country	Name	City	State
Israel	Beilinson Hospital, Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (8)

Gardner D, Shoback D. Greenspan's basic & clinical endocrinology, 9 edition. McGraw-Hill Companies, Inc.

Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2013.

Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013. — View Citation

Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS Lung Function Study Group. The prognostic importance of lung function in patients admitted with heart failure. Eur J Heart Fail. 2010 Jul;12(7):685-91. doi: 10.1093/eurjhf/hfq050. Epub 2010 Apr 15. — View Citation

Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS-Lung Function Study Group. Chronic obstructive pulmonary disease in patients admitted with heart failure. J Intern Med. 2008 Oct;264(4):361-9. doi: 10.1111/j.1365-2796.2008.01975.x. Epub 2008 Jun 5. — View Citation

Maxwell CB, Jenkins AT. Drug-induced heart failure. Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804. doi: 10.2146/ajhp100637. — View Citation

Schweiger TA, Zdanowicz M. Systemic corticosteroids in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Am J Health Syst Pharm. 2010 Jul 1;67(13):1061-9. doi: 10.2146/ajhp090293. — View Citation

Wei L, MacDonald TM, Walker BR. Taking glucocorticoids by prescription is associated with subsequent cardiovascular disease. Ann Intern Med. 2004 Nov 16;141(10):764-70. doi: 10.7326/0003-4819-141-10-200411160-00007. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in diuretic doses		Baseline, Week 2, Week 4
Primary	Length of hospital stay		up to 1 month
Primary	Change in COPD assessment tool (CAT) questionnaire score		Baseline, Week 2, Week 4
Primary	Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score		Baseline, Week 2, Week 4
Secondary	Rate of re-admission	rate of respiratory deterioration necessitate intubation, re-admission or death at 30-day post enrollment	30 days post enrollment